CMC Product Leader, Senior Director - T1D

Role: Senior Director, CMC Product Leader (T1D) for cell therapy; responsible for developing and executing integrated CMC strategies across development, scale-up, validation, regulatory submission, and commercialization. Core responsibilities include leading cross-functional teams covering process and analytical development, technology transfer, manufacturing readiness, regulatory strategy, and lifecycle management; partnering with stakeholders across BiopharmSci CGT, Manufacturing, Quality, Regulatory, Clinical, and Commercial functions; guiding technology transfer, manufacturing scale-up, and risk mitigation; preparing CMC content for regulatory filings; and managing budgets and resources. Requirements: Advanced degree in Chemical Engineering, Biotechnology, Biochemistry, or related field; 10+ years in CMC development and manufacturing within biotech/pharma, with significant cell therapy or regenerative medicine experience; proven leadership at Director or Senior Director level; experience with process development, regulatory submissions, and manufacturing scale-up. Preferred: PhD or MBA; experience in process validation, regulatory interactions, and commercialization of complex biologics. HighValue: cell therapy, regenerative medicine, CMC development, process transfer, regulatory strategy, scale-up, validation, IND/CTA/submission experience. WorkSetup: Hybrid or on-site; flexible work arrangements.